Manager - StatisticalPAT Expert

Job Description

Implement Statistical Process Control (SPC) principles, e.g. control charts, and other pattern recognition techniques. Support the compilation of APQRs. Review stability data and support definition of Internal Release Limits (IRL) and Out-of-Expectation (OOE) limits. Support creation of validation protocols (e.g. statistical sampling). Perform statistical analysis of process validation data for demonstrating validity and equivalence. Approve validation reports under area of responsibility (as needed) e.g. validation of PAT methods. Plan and evaluate Design of Experiments (DOEs) in the frame of the Quality by Design validation strategy. Facilitate and enable (multivariate) process monitoring and control principles, e.g. by Multivariate Data Analysis (MVDA). Support ongoing process verification by performing MVDA. Interacts with internal and external Regulatory bodies and Health Authorities, as well as internal functions as appropriate (e.g. during inspections, investigations etc.). Implement Statistical Process Control (SPC) principles, e.g. control charts, and other pattern recognition techniques. Support the compilation of APQRs. Review stability data and support definition of Internal Release Limits (IRL) and Out-of-Expectation (OOE) limits. Support creation of validation protocols (e.g. statistical sampling). EEO Statement Novartis is committed to building an outstanding, inclusive work environment and diverse team s representative of the patients and communities we serve.Minimum requirements What you ll bring to the role: Degree in Statistic, Mathematics, natural science or Chemical Engineering, MSc. Or PhD. Min 8+ years of proven experience in Pharma/Manufacturing sector in analytical lab in a GMP environment/equivalent. People Leadership Operations Management and Execution Project Management Collaborating across boundaries Functional Breadth Critical Negotiations English Quality Control (QC) Testing Knowledge of GMP Quality Standards Quality Assurance Experience in Automation and laboratory information management Data analytics and statistics for QA Stability design and interpretation Manufacturing Method Transfer and Validation Analytical quality by design, design of experiments 5+ years of relevant experience in Data Science Desirable: Excellent background on Statistical IT tools. Experience in Statistics on Drug Product and Oral Solid Dosage forms, Leading PAT projects end to end and delivering the appropriate trainings to stakeholders. Why Novartis 769 million lives were touched by Novartis medicines in 2020, and while we re proud of this, we know there is so much more we could do to help improve and extend people s lives.We believe new insights, perspectives and ground-breaking solutions can be found at the intersection of medical science and digital innovation. That a diverse, equitable and inclusive environment inspires new ways of working. We believe our potential can thrive and grow in an unbossed culture underpinned by integrity, curiosity and flexibility. And we can reinvent whats possible, when we collaborate with courage to aggressively and ambitiously tackle the world s toughest medical challenges. Because the greatest risk in life, is the risk of never trying!Imagine what you could do here at Novartis!Join our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about Novartis and our career opportunities, join the Novartis Network here: https://talentnetwork.novartis.com/network,

Keyskills :
quality by designitem response theorydesign of experimentsstatistical process controlcontinuous improvement facilitationdata sciencemusic makingstatistical process control spc